An interventional study of Sickle Cell Disease screening information management and communication system in Sickle Cell Disease, sponsored by Makerere University. Recruiting at 1 site in Uganda. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Makerere University · Not applicable, Interventional, and Health services research
A cluster randomized trial (CRT) of the novel sickle cell disease (SCD), M-health based SCD Information Management and Communication system SIMCS vs routine new born screening strategy in health care centres in Uganda to evaluate impact on access screening, coordination of care and clinical outcomes
We will conduct a cluster randomized trial (CRT) of the novel SCD SIMCS and utilize a logical framework of measurable indicators of barriers, utilization, mediating factors, and clinical outcomes of SCD screening and care to evaluate its impact. We will randomize health facilities rather than individual patients because it would be impossible to avoid contamination if we randomized individuals. This design is ideal for evaluating the effectiveness of systems level interventions.
Study procedures Trial Intervention. SCD SIMCS APP, which is an AI-enhanced mobile platform that captures, interprets and relays results of point of care tests for SCD to health care providers and to a centralised public data server at the Uganda Ministry of Health. The SCD SIMCS app prototype consists of four modules: (1) ID module - captures child's demographic and biometric data and builds a printable QR-code; (2) Assay module - captures HemoTypeSCTM and the Sickle Scan TM test image, interprets, and transmits results to the CPHL data centre; (3) Education module - stores and plays back short educational videos for pre- and post-screening counselling; (4) SCD e-Passport module - entry and display of child's longitudinal salient clinical information.
Baseline assessment; following stratified purposive sampling and consent from community leaders, Control and Experimental HCs will undergo baseline evaluation with regards to current resources and childcare visit workflows and the availability of the data sources and measurable indicators of interest. A baseline assessment of resources, workflows, and routine source data collection systems at the centres will facilitate implementation planning for the proposed SCD SIMCS and accurate measurement of its impact on the HCs.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
This study's planned enrollment of 24,000 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →Makerere University is the lead sponsor of 144 studies on the registry; 16 are open to participants now.
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Providers of child health and maternity services at selected hospitals Infants born or attending child health and maternity services at selected hospitals . Infants are the targeted age-group in this study because this is the ideal age to screen for SCD and prevent complications and mortality that generally occurs early, by 5 years old. The infants will be recruited at birth or at vaccination visits
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine new born screening strategy in health care centres in Uganda
Other: Sickle Cell Disease screening information management and communication system
Mobile Information Managment system
Other: Sickle Cell Disease screening information management and communication system
Mobile Health information managment system
Improved number and timeliness of refferal of infants with sickle cell disease for care
proportion with positive sickle cell disease screen recievign conformatory SCD test,penicillin , hydroxyurea
Time frame: 12 months
Ajusted Mortality Rate of children with sickle cell disease
Evaluate the impact of the SCD SIMCS on access to screening.
Time frame: 18 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jun 2027, 15 months after the start.
Of 165 non-industry interventional studies with no phase under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's planned 15 months is below that.
Counting every sponsor, half of 173 studies reached it within 28 months; a quarter within 15 and three quarters within 49.
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